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Prognostic Impact of Lesion-specific Hemodynamic Index in Patients With Coronary Artery Disease — PRIME-FFR  

Coronary Artery Disease Clinical Trial

Official title:
Prognostic Impact of Lesion-specific Hemodynamic Index and Disease Characteristics in Patients With Coronary Artery Disease Assessed by Fractional Flow Reserve

Clinical Trial Summary

The investigators aim to investigate the additive prognostic value of lesion-specific hemodynamic index such as ΔFFR, non-hyperemic pressure ratio such as RFR, over % diameter stenosis and FFR according to treatment strategy, and to find the prognostic implications of post-PCI FFR after adjustment of various clinical and disease characteristics, and to construct a comprehensive risk prediction model for post-PCI outcomes.

Clinical Trial Description

Fractional flow reserve (FFR)-based revascularization is the currently best practice recommended by guidelines. In addition to the use of coronary physiological indices as a vessel-specific metric, recent studies suggested the clinical importance of local hemodynamics in prediction of risk for target vessel failure or acute coronary syndrome in patients with coronary artery disease. In patients who receive percutaneous coronary intervention (PCI), the absolute value and pattern of FFR change after stenting are helpful in defining the additional target for PCI and risk stratification after PCI. However, there has been no prospective study that proved the benefit of change in FFR across the lesion (ΔFFR) in daily clinical practice, and FFR usage after stenting is much less than before stenting. Accordingly, we will prove the benefit of ΔFFR in addition to FFR, prognostic implications of combining RFR and FFR, and the comprehensive risk model with post-PCI FFR, clinical and disease characteristics in a prospective study, to maximize the benefit of invasive physiologic assessment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05250557
Study type Observational
Source Seoul National University Hospital
Contact Bon-Kwon Koo, MD, PhD
Phone +82-2-2072-2062
Email bkkoo@snu.ac.kr
Status Recruiting
Phase
Start date August 1, 2021
Completion date December 31, 2026
View Details
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